BS EN 13312-2-2001 Biotechnology - Performance criteria for piping and instrumentation - Couplings《生物技术 管道和仪表性能标准 耦合》.pdf

1、BRITISH STANDARD BS EN 13312-2:2001 Biotechnology Performance criteria for piping and instrumentation Part 2: Couplings The European Standard EN 13312-2:2001 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13312-2

2、2001 This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 April 2001 BSI 04-2001 ISBN 0 580 37457 2 National foreword This British Standard is the

3、 official English language version of EN 13312-2:2001. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-referen

4、ces The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalog

5、ue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text;

6、 present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside fr

7、ont cover, the EN title page, pages 2 to 9 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN133122 February2001 ICS07.080;07.100.

8、01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart2:Couplings BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie2:Raccords BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungTeil2:Verbindungsstcke ThisEuropeanStandardwasapprovedbyC

9、ENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManage

10、mentCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstand

11、ardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeSt

12、assart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133122:2001EPage2 EN133122:2001 Contents Page Foreword.3 Introduction 4 1 Scope.4 2 Normativereferences .4 3 Termsanddefinitions.5 4 Hazards5 5 Performanceclasses 5 6 Classif

13、icationandverificationofperformance.6 7 Markingandpackaging 6 8 Documentation6 AnnexA(informative)Guidanceontestmethodsfordetermining leaktightness,cleanabilityandsterilizabilityofcouplings .7 AnnexB(informative)Design,installationandmaintenanceofcouplings8 Bibliography .9Page3 EN133122:2001 Forewor

14、d ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,and conflictingnationalstandardsshallbewith

15、drawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thesestandardsare: EN133121, BiotechnologyPerf

16、ormancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinoculationdevices. EN133124, BiotechnologyPerfor

17、mancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. ThisstandardincludesaBibliography. AccordingtotheCEN/CENELECI

18、nternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN

19、133122:2001 Introduction Couplingsareusedforjoiningtubularsections,andforconnectingothercomponentsof equipmentintotheprocesssystem,whereequipmentisdesignedtobedisassembled.In manycasescouplingsaremadeofstainlesssteelandareusedinallfood,beverage, pharmaceuticalandbiotechnologicalprocesses. Detailedde

20、signspecificationsarenecessarytoensureinterchangeabilityandconnectability, sincefrequentlythevariouspartsofacouplingwillbemanufacturedbydifferent organisations.Asanexample,controlandmeasuringdevicesareoftensuppliedwith couplingsontheconnectingportswhichhavetobesecuredtotubesystemswithmating partsand

21、gasketssuppliedbythirdparties. Couplingsaredesignedtobeleakproofundernormaloperatingconditions.In biotechnologicalapplicationstheyshouldinrelevantcasespreventthereleaseof microorganismsintotheatmosphereandingressintotheprocesssystem.Couplingsshould enableprocessequipmenttobecleanedinplaceordismantle

22、dformanualcleaningand/or sterilizationinanautoclave.Typicalcouplingstandardsaregiveninbibliography3to10. Inrelevantcasescouplingsthemselvesshouldbecapableofbeingcleanedand/orsterilized inplace. Thecontinuouslyreliableperformanceofacouplingisdependentonfeaturesand conditionswhicharenotintegralpartsof

23、thisEuropeanStandard,andthereforeattentionis drawntotherecommendationsfordesign,installationandmaintenanceinannexB. UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof couplingswithregardtosafeperformanceinbiotechnologicalprocesses.Theclassification iseasilyunderstandablean

24、dreadilyutilizablefortheuserandtheregulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforcouplingsusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofthecoupli

25、ngincludeshazardous orpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesorwhere exposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedforreasons ofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thes

26、enormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicatio

27、nreferredtoapplies(includingamendments).Page5 EN133122:2001 EN133121:2001, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply. 4 Hazards Thefollowinghazardss

28、hallbetakenintoaccount. a)Releaseofmicroorganismscausedby: noncompatibilityofcouplings,gasketsand/orfittings; misalignmentofthecouplingduringassembly; replacementofthespecialisedgaskets,specifiedforaparticularprocessand couplingdesign,withsimilarproduct,forexampleOrings,whicharenotsuitablefor theser

29、vicedemanded; loosenessofcouplingsinserviceresultingfromexpansion,contractionand vibrations; NOTE1Theextenttowhichthegasketmaterialcanbecompressedorexpandedby mechanical,heatorvacuumconditionsiscontrolledbythechoiceofcouplingdesign, materialsusedandmanufacturingtolerances. misalignmentresultingfromr

30、epetitiveuseofgasketsforclampcouplings. b)Overtighteningofcouplingsdesignedtohaveasealwhichisflushedwiththeinner boreofthetubesystemcancausethegaskettoextrudeintotheboreorcandamagethe surfaceoftheseal,therebyreducingtheeffectivenessofcleaningandsterilization. c)Protectionofviablehazardousmicroorgani

31、smsincracksandfissureswithinthe elastomer.Gasketmaterialsdegradeatvaryingrates,canbepermeatedwith microorganismsandcanentrapsoilormicroorganismswithincouplingsealcavitiesthus reducingtheefficiencyofcleaningandsterilization. NOTE2Repeatedexpansionandcontractionofelastomergasketsduetovariable pressure

32、sandtemperaturescancausedeteriorationoftheelastomer. 5 Performanceclasses Thecouplingshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityin accordancewith5.1to5.4ofEN133121:2001. Theselectionoftheappropriateclassforperformanceofacouplingshallbemadein accordancewith5.5ofEN133121:2001.Page

33、6 EN133122:2001 6 Classificationandverificationofperformance 6.1 General Thecouplingshallconformtothegeneralrequirementsgivenin6.1ofEN133121:2001. Couplingsthatareanintegralpartofaunitofequipment,i.e.avesselwithinletandoutlet ports,shallmeettheperformancerequirementsforthatunitofequipment. NOTEStand

34、ardsforhygieniccouplingscannotguaranteeconformanceto processeswherepotentiallyhazardousmicroorganismsareused. Referencestotestmethodstotesttheperformanceofcouplingswithregardto leaktightness,cleanabilityandsterilizabilityaregiveninannexA. 6.2 Leaktightness Thecouplingshallconformtotherequirementsgiv

35、enin6.2ofEN133121:2001. NOTEGenerallycouplingsaredesignedtobeleaktighttoaspecifiedmaximum pressureandcanbeverifiedbypressuretestingwhennecessary.Pressuretesting aloneisnotproofofleaktightnessformicrobiologicaluse. 6.3 Cleanability Thecouplingshallconformtotherequirementsgivenin6.3ofEN133121:2001. 6.

36、4 Sterilizability Thecouplingshallconformtotherequirementsgivenin6.4ofEN133121:2001. 7 Markingandpackaging Thecouplingshallconformtotherequirementsgivenin clause7ofEN133121:2001. 8 Documentation Thecouplingshallconformtotherequirementsgivenin clause8ofEN133121:2001.Page7 EN133122:2001 AnnexA(informa

37、tive) Guidanceontestmethodsfordeterminingleaktightness,cleanabilityand sterilizabilityofcouplings A.1 Leaktightness AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see11).From thatlistsuitabletestmethodstothetestingofcouplingsaregivenintableA.1. TableA.1Suitablealternativeleaktightnesst

38、estmethodsforcouplings Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 8 Tracerliquiddyes 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 13 Productaerosol(nonmicrobial) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 1

39、6 Surfaceswabbing 18 Visualinspection(onlyqualitative) 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsemen

40、tofCENoftheseproducts A.2 Cleanability Asuitablemethodfortestingcleanabilityisdescribedin1. A.3 Sterilizability Asuitablemethodfortestingsterilizabilityisdescribedin2.Page8 EN133122:2001 AnnexB(informative) Design,installationandmaintenanceofcouplings B.1 Couplingsdesign Couplingscanbedesignedtoenab

41、lerepeatedcleaninginplace(CIP)andsterilizingin place(SIP)operationstobecarriedoutattherequiredtemperaturesandtimecycles withoutaffectingthetightnessoftheconnectionorcausingunduedeteriorationofthe gasketmaterial.Ideally,thegasketsurfaceistobeflushedwiththeinternalboresurfacesof thecouplingsduringnorm

42、aloperationofthesystemreducingtheinstancesofcavitiesand flowrestrictions. B.2 Couplingsinstallation B.2.1 General Whencouplingsareinstalled,thefollowingdisciplinesshouldbeobserved. B.2.2 Thecomponentsshouldbeexaminedandpreassembledtoensurethattheywillfit togethercorrectly,particularlywithrespecttoth

43、ealignmentoftheboresandthefitofthe gaskets. B.2.3 Componentsgetpreferablyconnectedbytheorbitalweldingprocess.Careshould betakentoensurethatthecouplingcomponenthasnotbeendistortedbythewelding procedure.TIG 1) weldingshouldbeusedforallweldsincontactwithproduct.Internal penetrationofrootpassesshouldbes

44、moothandlimitedinsize. B.2.4 Careshouldbetakentoensureproperalignmentofthetwohalvesofacoupling whenassembled,particularlywherepipeworkisconcerned.Assembledmisalignmentisthe mostcommonfaultcausingleakage. B.2.5 Allcouplingsshouldbecheckedandfinallytightenedbeforetheequipmentof processsystemisputintoservice. B.3 Maintenance B.3.1 Themanufacturerorusershoulddefinethe